Trials and tribulations

India’s poor are unknowingly taking part in clinical trials for drugs by Indian and multinational pharmaceutical companies that outsource the work to unregulated research organizations

By Abhaya Srivastava / AFP, New Delhi

Indian heart patient Niranjan Lal Pathak poses at his residence in Indore last September. Pathak’s family says that a hospital in Indore offered free treatment for a heart complaint, but were actually going to enroll him in trials for an untested drug

Photo: AFP

Niranjan Lal Pathak couldn’t believe his luck initially. When a doctor at a hospital in central India offered the factory watchman free treatment for a heart complaint, he jumped at the chance.

It was five years ago and the family of the 72-year-old says he didn’t realize that the Maharaja Yashwantrao Hospital in the city of Indore was about to enroll him in a trial of an untested drug.

“We were told that our uncle will be treated under a special project,” his nephew Alok Pathak told AFP over the phone from Indore, the largest city of Madhya Pradesh state.

“The doctor said we wouldn’t have to spend a penny. There was only one condition placed before us — that we should not approach local chemists if we ever ran out of his medicines but go straight to the doctor,” he said.

A petition filed by the family in India’s Supreme Court alleges that the drug tested on him was Atopaxar, developed by Japan-based pharmaceutical company Eisai and supposed to treat anxiety disorders.

His family and health rights group Swasthya Adhikaar Manch (Health Rights Platform) say that he would never have enrolled for the trial had he known that an untested drug would be administered.

The family also claims that the side-effects of the drug left Pathak suffering from dementia.

“He barely recognizes us. His life is finished and so are our hopes to see him healthy and happy again,” Alok told AFP, his voice choked with emotion.

Many desperate and poor people in India are unwittingly taking part in clinical trials for drugs by Indian and multinational pharmaceutical companies that outsource the work to unregulated research organizations.

The record of Pathak’s treatment was maintained on a medical card and his family is now fighting a legal battle, one of scores of cases brought by people who say they are victims of illegal trials.

A booming business

Testing pharmaceuticals on humans is a mandatory and expensive step for drug companies who must prove to regulatory authorities that treatments have no dangerous side-effects in order to bring them to market.

The Confederation of Indian Industry estimates that companies save up to 60 percent by undertaking the different phases of testing a new drug in India as compared to developed countries.

The clinical research market in India grew by 12.1 percent in 2010 and 2011 with revenues of US$485 million, according to report by Frost and Sullivan, a global business research and consulting firm.

The study, released in July last year, projected the industry to reach the one-billion dollar mark by the end of 2016.

But the legal case in the Supreme Court, which began in February last year, has helped to bring to light many of the alleged misdeeds by doctors in connivance with pharmaceutical companies.

“There has to be some sense of responsibility. Human beings are treated like guinea pigs,” Supreme Court judges R.M. Lodha and A.S. Dave said last year in a written statement.

In Pathak’s case, the hospital says the doctor who treated him administered the drug without authorization and had since left the institution, while Eisai declined to comment, saying it was unable to respond to enquiries on individuals.

“Eisai is committed to making a meaningful contribution under any healthcare system and undertaking all of its activities adhering to the highest legal and ethical standards,” it said in an e-mail to AFP.